Overcoming recruitment barriers revealed high readiness to participate and low dropout rate among people with schizophrenia in a randomized controlled trial testing the effect of a Guided Self-Determination intervention.

Bottom Line:
GSD is a shared decision-making and mutual problem-solving method using reflection sheets, which was developed in diabetes care and adjusted for this study and utilized by patients with schizophrenia.These challenges were overcome through: 1) extension of time, 2) expansion of the clinical recruitment area and 3) encouragement of professionals to invite patients to the study.Through overcoming these challenges, we identified a remarkably high patient-readiness to take part (101 of 120 asked accepted) and a low dropout rate (8%).

Background: Recruitment is one of the most serious challenges in performing randomized controlled trials. Often clinical trials with participants diagnosed with schizophrenia are terminated prematurely because of recruitment challenges resulting in a considerable waste of resources in the form of time, funding, and the participants' efforts. Dropout rates in schizophrenia trials are also high.Recruitment challenges are often due to patients not wanting to participate in research but can also be due to clinicians' concerns regarding individuals diagnosed with schizophrenia as participants in research. This paper reports how overcoming recruitment challenges not related to patients revealed high readiness to take part and low dropout rates in a one year long randomized controlled trial testing Guided Self-Determination (GSD) among outpatients with schizophrenia receiving treatment in Assertive Outreach Teams in the northern part of Denmark.

Methods: GSD is a shared decision-making and mutual problem-solving method using reflection sheets, which was developed in diabetes care and adjusted for this study and utilized by patients with schizophrenia. Descriptive data on strategies to overcome recruitment challenges were derived from notes and observations made during the randomized controlled trial testing of GSD in six outpatient teams.

Results: Three types of recruitment challenges not related to patients were identified and met during the trial: 1) organizational challenges, 2) challenges with finding eligible participants and 3) challenges with having professionals invite patients to participate. These challenges were overcome through: 1) extension of time, 2) expansion of the clinical recruitment area and 3) encouragement of professionals to invite patients to the study. Through overcoming these challenges, we identified a remarkably high patient-readiness to take part (101 of 120 asked accepted) and a low dropout rate (8%).

Conclusion: Distinction between recruitment challenges was important in discovering the readiness among patients with schizophrenia to take part in and complete a trial with the GSD-intervention.

Mentions:
In addition to the delay in the implementation plan, the number of expected eligible participants for the trial decreased. The AOTs were expected to treat approximately 300 patients, and it was also expected that 90 to 95% of the patients (n = 280) in the AOTs would have a diagnosis of schizophrenia. In total, 24 MHCPs were expected to be employed, but due to changes in the implementation plan the actual number was 18 MHCPs, which reduced the total patients by a third. Some MHCPs resigned, and new ones were employed, but the total number was 18 MHCPs during the entire trial period. Without any proper explanation, the number of patients with a diagnosis of schizophrenia was smaller than expected. It appeared that only between 60 and 65% of the patients treated in the AOTs had schizophrenia, 30 to 35% less than expected. Looking at the numbers of patients in the three AOTs when the recruitment period ended, we found that 201 patients were treated in the AOTs and only 128 met the inclusion criteria for the trial. Five MHCPs from the AOTs did not participate in the trial; therefore 34 eligible participants were not approached or asked to participate in the trial. In total 94 eligible participants were present in the three AOTs compared to the expected 280 eligible participants in the implementation plan, a reduction of 66% (Figure 3: Flowchart for recruitment).

Overcoming recruitment barriers revealed high readiness to participate and low dropout rate among people with schizophrenia in a randomized controlled trial testing the effect of a Guided Self-Determination intervention.

Mentions:
In addition to the delay in the implementation plan, the number of expected eligible participants for the trial decreased. The AOTs were expected to treat approximately 300 patients, and it was also expected that 90 to 95% of the patients (n = 280) in the AOTs would have a diagnosis of schizophrenia. In total, 24 MHCPs were expected to be employed, but due to changes in the implementation plan the actual number was 18 MHCPs, which reduced the total patients by a third. Some MHCPs resigned, and new ones were employed, but the total number was 18 MHCPs during the entire trial period. Without any proper explanation, the number of patients with a diagnosis of schizophrenia was smaller than expected. It appeared that only between 60 and 65% of the patients treated in the AOTs had schizophrenia, 30 to 35% less than expected. Looking at the numbers of patients in the three AOTs when the recruitment period ended, we found that 201 patients were treated in the AOTs and only 128 met the inclusion criteria for the trial. Five MHCPs from the AOTs did not participate in the trial; therefore 34 eligible participants were not approached or asked to participate in the trial. In total 94 eligible participants were present in the three AOTs compared to the expected 280 eligible participants in the implementation plan, a reduction of 66% (Figure 3: Flowchart for recruitment).

Bottom Line:
GSD is a shared decision-making and mutual problem-solving method using reflection sheets, which was developed in diabetes care and adjusted for this study and utilized by patients with schizophrenia.These challenges were overcome through: 1) extension of time, 2) expansion of the clinical recruitment area and 3) encouragement of professionals to invite patients to the study.Through overcoming these challenges, we identified a remarkably high patient-readiness to take part (101 of 120 asked accepted) and a low dropout rate (8%).

Background: Recruitment is one of the most serious challenges in performing randomized controlled trials. Often clinical trials with participants diagnosed with schizophrenia are terminated prematurely because of recruitment challenges resulting in a considerable waste of resources in the form of time, funding, and the participants' efforts. Dropout rates in schizophrenia trials are also high.Recruitment challenges are often due to patients not wanting to participate in research but can also be due to clinicians' concerns regarding individuals diagnosed with schizophrenia as participants in research. This paper reports how overcoming recruitment challenges not related to patients revealed high readiness to take part and low dropout rates in a one year long randomized controlled trial testing Guided Self-Determination (GSD) among outpatients with schizophrenia receiving treatment in Assertive Outreach Teams in the northern part of Denmark.

Methods: GSD is a shared decision-making and mutual problem-solving method using reflection sheets, which was developed in diabetes care and adjusted for this study and utilized by patients with schizophrenia. Descriptive data on strategies to overcome recruitment challenges were derived from notes and observations made during the randomized controlled trial testing of GSD in six outpatient teams.

Results: Three types of recruitment challenges not related to patients were identified and met during the trial: 1) organizational challenges, 2) challenges with finding eligible participants and 3) challenges with having professionals invite patients to participate. These challenges were overcome through: 1) extension of time, 2) expansion of the clinical recruitment area and 3) encouragement of professionals to invite patients to the study. Through overcoming these challenges, we identified a remarkably high patient-readiness to take part (101 of 120 asked accepted) and a low dropout rate (8%).

Conclusion: Distinction between recruitment challenges was important in discovering the readiness among patients with schizophrenia to take part in and complete a trial with the GSD-intervention.